Chemotherapy-Induced Nausea and Vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen) MedDRA version: 20.0 Level: LLT Classification code 10008443 Term: Chemotherapy antiemetic prophylaxsis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10054133 Term: Prophylaxis of nausea and vomiting System Organ Class: 10042613 - Surgical and medic
Conditions
Interventions
Trade Name: Akynzeo
Product Name: Akynzeo
Product Code: NEPA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Netupitant/palonosetron
Current Sponsor code: NEPA
Concentration unit: mg milligram
Sponsors
CONSORZIO ONCOTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – Women >= 18 years old. – Histologically or cytologically confirmed diagnosis of breast cancer. – Na¿f patients. – Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclofosfamide (AC-based regimen). – ECOG Performance Status 0-2. – Body Mass Index (BMI) >= 18.5. – Written informed consent. – If women of childbearing potential age: reliable contraceptive measures must be used. – Normal hepatic function (=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: – Advanced/metastatic breast cancer. – Patients already submitted to non-AC-based chemotherapy. – Treatment with investigational medications within 30 days before NEPA. – Myocardial infarction within the last 6 months. – Documented or known hypersensitivity to 5HT3RA or NK1RA and excipients. – Uncontrolled diabetes mellitus. – Nausea and vomiting at baseline. – Chronic use of other antiemetic agent(s). – Patient’s inability to take oral medication. – Gastrointestinal obstruction or active peptic ulcer. – Pregnancy or breastfeeding – Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for >= 5 years. – Psychiatric or CNS disorders interfering with ability to comply with study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase;Timepoint(s) of evaluation of this end point: during the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles.;Main Objective: To evaluate if the activity of one day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles);Secondary Objective: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • rate of complete response (no vomiting and no use of rescue medication) • rate of complete control (defined as complete response with a maximum grade of mild nausea) • rate of emesis-free patients • severity of nausea graded according to Likert • patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS) • Safety profile.;Timepoint(s) of evaluation of this end point: During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles, up to 4 cycles | — |
Countries
Italy
Contacts
Public ContactCRO
Clinical Research Technology
Outcome results
None listed